Premarket Notification Requirements for Gastroenterology and Urology Biopsy Devices
This guidance outlines the requirements for premarket notifications (510(k)) for biopsy devices used in gastroenterology and urology, including biopsy instruments, endoscopes and accessories, and endoscopic electrosurgical units and accessories classified as Class II devices.
What You Need to Know? 👇
What are the main FDA classifications for gastroenterology and urology biopsy devices?
Biopsy devices fall under three classifications: 21 CFR 876.1075 (Gastroenterology-Urology Biopsy Instruments), 21 CFR 876.1500 (Endoscopes and Accessories), and 21 CFR 876.4300 (Endoscopic Electrosurgical Unit and Accessories). All are Class II devices requiring 510(k) premarket notification.
What biocompatibility testing is required for biopsy devices used in gastroenterology and urology?
Biopsy devices are considered short-term implants and require biocompatibility testing including irritation, sensitization, cytotoxicity, acute systemic toxicity, and implantation tests. Testing requirements follow the Tripartite Biocompatibility Guidance for Medical Devices and depend on patient contact materials.
What functional testing data must be included in a 510(k) submission for automatic biopsy devices?
Functional testing must demonstrate needle advancement and penetration accuracy, multiple sampling capability if claimed, sample quality consistency across shots, and electrical safety for powered devices. Testing should simulate actual medical procedure conditions using statistically valid sample sizes.
What labeling requirements apply to gastroenterology and urology biopsy devices?
Labels must include the FDA caution statement restricting sale to physicians, intended use with specific anatomical sites, comprehensive directions for use, contraindications, precautions, warnings, sterility status, and clear identification of single-use versus reusable components.
What sterilization information is required for sterile biopsy devices in 510(k) submissions?
Submissions must include sterilization method, validation procedures, packaging materials, sterility assurance level (SAL), radiation dose or ethylene oxide residual levels, and pyrogen testing methods if applicable. Non-sterile parts must be clearly identified in labeling.
How should substantial equivalence be demonstrated for biopsy devices in 510(k) submissions?
Substantial equivalence requires comparison with legally marketed predicate devices covering intended use, design specifications, energy delivery, materials, performance, target population, and anatomical sites. Differences must be supported by clinical or scientific data demonstrating maintained safety and effectiveness.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including physical specifications and diagrams
- Conduct required biocompatibility testing for patient-contacting materials
- Perform functional testing appropriate for the device type
- Develop complete labeling package with all required elements
- Prepare sterilization validation if applicable
- Document substantial equivalence comparison with predicate devices
- Compile material and component information
- Prepare kit certification if marketing as a kit
- Validate electrical safety for powered devices
- Ensure all testing follows accepted industry standards
Key Considerations
Non-clinical testing
- Functional testing required for:
- Cytology brushes: electrical compatibility, motor speeds, brush rotation, suction pressures
- Automatic biopsy devices: needle advancement and penetration testing
- Electric biopsy forceps: electrical compatibility and safety testing
- Testing should be conducted with statistically valid sample sizes
- Testing should follow accepted industry standards
Labelling
- Must include device name, U.S. point of contact, corporation details
- Specific intended use statement with anatomical sites and target population
- Comprehensive directions for use including preparation, operation, and maintenance
- Contraindications, precautions, and warnings
- Sterility status and expiration date if applicable
- Single use/disposable parts identification
Biocompatibility
- Required testing for short-term implants:
- Irritation
- Sensitization
- Cytotoxicity
- Acute systemic toxicity
- Implantation
- Testing needed for any material or colorant changes
Safety
- Electrical safety testing for powered devices
- Sterility validation if sold sterile
- Sterilization instructions if sold non-sterile
- Pyrogen testing if labeled as pyrogen-free
Other considerations
- Physical description with labeled diagrams required
- Material identification and processing information
- Kit components certification if marketed as a kit
- Summary of equivalence comparing to legally marketed devices
Relevant Guidances 🔗
- 510k Submissions for Mechanical Lithotripters and Stone Dislodgers in Gastroenterology and Urology
- Ureteral Stents - Content and Testing Requirements for 510k Submissions
- Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention
- Premarket Notification Requirements for Urine Drainage Bags and Accessories
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms 📂
- 21 CFR 876.1075: Gastroenterology-Urology Biopsy Instruments
- 21 CFR 876.1500: Endoscopes and Accessories
- 21 CFR 876.4300: Endoscopic Electrosurgical Unit and Accessories
- 21 CFR 807.87: Content requirements for premarket notification
Original guidance
- Premarket Notification Requirements for Gastroenterology and Urology Biopsy Devices
- HTML
- Issue date: 1993-02-09
- Last changed date: 2020-03-17
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta ID: 0ff9c0c6cf1265e03112b8cb0ac2d92b